RadNet Gets FDA Nods for AI-Powered Mammography and Prostate MRI Software Algorithms

RadNet has garnered 510(k) clearances from the Food and Drug Administration (FDA) for the artificial intelligence (AI)-enabled algorithms Saige-Dx™, which aids in detecting suspicious findings on mammograms, and Quantib® Prostate 2.0, which may bolster reporting of prostate magnetic resonance imaging (MRI) exams.

Saige-Dx reportedly enhances the detection of suspicious lesions on mammograms and reduces recalls, according to RadNet. Built on advanced deep learning algorithms, Saige-Dx decreased false positive rates and improved the ability of 18 radiologists to detect cancer in a study that preceded the FDA 510(k) clearance, noted DeepHealth, a subsidiary of RadNet.

Quantib Prostate 2.0 provides automated segmentation of prostate zones and glands as well as lesion localization on the PI-RADS sector map, according to RadNet.

The company noted that the software program enhances the quality and speed of reporting with prostate MRI exams. RadNet said other benefits of Quantib Prostate 2.0 include PSA density calculation, PI-RADS scoring support and one-click segmentation of possible lesions.

“Artificial intelligence will have a transforming impact on radiology and cancer care, and we are committed to delivering those advances to patients and health-care providers,” noted Howard Berger, the president and chief executive officer of RadNet. “ … We believe that these AI tools will play an important role in the early detection and diagnosis of cancer, resulting in improved survival rates and better patient outcomes.”